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Phase II study of NS-17 in elderly patients with acute myeloid leukemia.

Phase II study of NS-17 in elderly patients with acute myeloid leukemia.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223699
Enrollment
50
Registered
2017-11-01
Start date
2018-01-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myeloid leukemia

Interventions

investigational material(s) Generic name etc : NS-17 INN of investigational material : Azacitidine Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Sponsors

Nippon Shinyaku Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. AML patients who are diagnosed of one of the following: Newly diagnosed, histologically confirmed de novo AML or, AML secondary to prior myelodysplastic disease or, AML secondary to exposure to potentially leukemogenic therapies or agents with the primary malignancy. 2. Patients with bone marrow blasts>=30%. 3. Patients whose ECOG PS is 0, 1 or 2

Exclusion criteria

Exclusion criteria: 1. Patients with previous cytotoxic treatment for AML. 2. Patients with previous treatment with hypomethylating agents or cytarabine.

Design outcomes

Primary

MeasureTime frame
efficacy Overall survival

Secondary

MeasureTime frame
efficacy One-year overall survival rate

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026